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Quality & Compliance

The Quality & Compliance section explains how Shandong Nametai Biotechnology Co., Ltd. controls quality, which certifications are held, and what documentation buyers can expect to receive. It is written for procurement, QA and regulatory teams performing supplier due diligence on MCT oil, medium-chain triglycerides and fatty acid esters.

Pharmaceutical & Food-Grade Compliance

Our manufacturing base is located in the Yellow River Delta Agricultural High-tech Zone, Dongying, Shandong, China. MCT oil, MCT microencapsulated powder and fatty acid esters are produced under a food production licence issued for this site, and materials intended for pharmaceutical or cosmetic use are supplied against agreed specifications rather than off-the-shelf grades.

We do not claim a GMP certificate, a USP/EP monograph approval, a DMF or a CEP that we have not been issued. Where a buyer requires a pharmaceutical-grade material, the applicable specification, testing regime and documentation set are agreed in writing before order confirmation, and testing can be carried out under an agreed protocol by a third-party laboratory.

Quality Control

Every batch is released against a full specification. In-house QC tests the fatty acid profile by gas chromatography (GC), acid value, peroxide value, moisture and impurities on each lot. Heavy metals and microbiology are tested to food-grade requirements. Retained samples are kept for full batch traceability.

Typical values for our MCT oil are published on the relevant product pages. Combined C8:0 + C10:0 content is ≥ 99% (typical 57.6% C8 / 42.3% C10, tested by third-party laboratory CTI). Typical acid value is 0.04 mg/g and typical peroxide value is 0.28 mmol/kg. Lead and arsenic have not been detected, and synthetic antioxidants (TBHQ/BHA/BHT) have not been detected. 3-MCPD esters and glycidyl esters are controlled — glycidyl esters were not detected in recent third-party testing, which is a key requirement for European food and infant-nutrition buyers.

Certifications

The following certifications and registrations are held by Shandong Nametai Biotechnology Co., Ltd. Scans are published in the Certification section:

  • ISO 9001 — quality management system
  • ISO 22000 — food safety management system
  • ISO 14001 — environmental management system
  • ISO 45001 — occupational health and safety management system
  • HACCP — hazard analysis and critical control points
  • U.S. FDA registration — food facility registration
  • Halal — Halal Foundation Center certification
  • Kosher — Kosher certificate (SKS Shatz), Pareve
  • Business licence and China food production licence SC20137052301879

Certificates are issued in the name of the manufacturer. Buyers who need a certificate in a specific language, or an in-date copy sent directly, should contact us with the certificate name and the intended use.

Documentation Support

Documentation is supplied with each shipment against the agreed specification. Depending on the product and destination, this can include a Certificate of Analysis (COA), Safety Data Sheet (MSDS), certificate of origin, health certificate, and Halal or Kosher certification as required. Statements on this page describe what we are able to supply — they are not a substitute for the documentation that accompanies a specific order, which is confirmed in the order documents.

For product-specific documentation such as a technical data sheet, specification sheet or typical fatty acid profile, please contact us and state the product and the application.

Factory Verification

Because sourcing decisions in this industry depend on being able to verify the producer, we support buyer due diligence directly:

  • Factory visit and audit — buyers and their appointed third-party inspection bodies are welcome to visit the production base in Dongying by appointment.
  • Live video walkthrough — for buyers who cannot travel, we can arrange a live video tour of the production and warehouse areas.
  • Factory photos and video — published on our Factory page, covering the production workshop, processing equipment, packaging and warehouse, and the quality control laboratory.
  • Batch traceability — retained samples are kept per batch so a delivered lot can be traced back to its production record.

Contact for Compliance Enquiries

For specifications, certificates, sample requests or to arrange a factory visit or audit, contact our team directly:

Shandong Nametai Biotechnology Co., Ltd.
Address: Building 5, Big Health & Functional Food Industry Research Institute and Pilot Base, Binhai New Kinetic Energy Industrial Park, Yellow River Delta Agricultural High-tech Zone, Dongying, Shandong, China
Tel / WhatsApp: +86 132 9546 7567
E-mail: [email protected]

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